Viewing the right 483 is helpful, analyzing 100K+ enforcement documents is powerful

Dive into the largest database of FDA 483s and global enforcement documents.

This demo will teach you how to:

  • Search over 25K 483s to find the one you need
  • Examine Investigator Profiles for inspection prep
  • Analyze inspection outcomes mapped to quality system
  • View 300,000+ Site and Organization profiles with full inspection history

Integrated data, intelligence,
visualizations, and workflows

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Unmatched Data

Proprietary data sourcing powered by the Freedom of Information Act (FOIA)
and web crawling from >15,000 individual data sources

  • >200 Agencies and Standards bodies
  • Industry coverage includes: Human Drugs, Biologics, Medical Devices & IVD, Combination Products, Animal Health, and Food
  • GxP coverage includes: GLP, GMP, GCP, GMP for IMP, GVP, and GDP
  • >4,500 Inspector Profiles
  • >300,000 Site and Organization Profiles
  • >100k regulatory documents – 483s, Warning Letters, Untitled Letters, Certificates of Non-Conformance, Regulations, Guidance, etc

Deep Intelligence

We seamlessly integrate data science capabilities with expert intelligence- including AI, natural language processing, machine learning, into the data pipeline to extract additional value.

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Bringing everything together

Our team assimilates, normalizes, and categorizes large amounts of unstructured data to make sure all entities are represented and connected. The RedicaID provides a real-time view into evolving data by tracking inspections, enforcement actions, regulatory publications, and M&A activity. In a complex landscape that’s always in flux, the RedicaID is a reliable constant.

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